The following data is part of a premarket notification filed by Hk Surgical, Inc. with the FDA for Klein Surgical Infiltration Pump, Model Kip-ii.
Device ID | K031432 |
510k Number | K031432 |
Device Name: | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II |
Classification | Pump, Infusion |
Applicant | HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
Contact | Sally M Bowdon |
Correspondent | Sally M Bowdon HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-06 |
Decision Date | 2003-08-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08169890200135 | K031432 | 000 |
08169890200128 | K031432 | 000 |